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Safety and efficacy of alirocumab: A meta analysis of 12 randomized controlled trials
1Department of Pharmacology, AIIMS, Bhopal, Madhya Pradesh, India.
Insights
Alirocumab significantly lowers LDL cholesterol by over 50% and improves HDL cholesterol in adults with hypercholesterolemia. This PCSK9 inhibitor offers a promising new treatment for managing high cholesterol levels.
Area of Science:
- Cardiology
- Pharmacology
- Metabolic Disorders
Background:
- Hypercholesterolemia is a primary risk factor for atherosclerotic coronary heart disease.
- Statins are effective but often fail to achieve target LDL-C levels (<70 mg/dL) in high-risk patients.
- Monoclonal antibodies targeting PCSK9 represent a novel therapeutic class for hypercholesterolemia.
Purpose of the Study:
- To systematically assess the safety and efficacy of Alirocumab.
- To evaluate Alirocumab's impact on lipid profiles in adults with hypercholesterolemia and Familial Hypercholesterolemia.
Main Methods:
- A systematic review and meta-analysis of Phase 3 randomized controlled trials (RCTs).
- Searched major databases (Medline, PubMed Central, Google Scholar) and clinical trial registries up to March 2017.
- Included twelve RCTs involving 6019 patients.
Main Results:
- Alirocumab demonstrated a substantial reduction in LDL-C levels, exceeding 50%.
- Significant favorable changes were observed in HDL-C levels.
- Other lipid parameters also showed beneficial alterations.
Conclusions:
- Alirocumab effectively reduces LDL-C and improves HDL-C in patients with hypercholesterolemia.
- The study provides evidence for Alirocumab's efficacy in lipid management.
- Results were based on study-level data, not individual patient data.
Background And Objective:
Hypercholesterolemia is one of the major risk factor for atherosclerotic coronary heart disease, especially coronary heart disease. Most effective class of medications for prevention of cardiovascular events and LDL-C reduction are the statins. Approximately only one fourth of these high risk patients had achieved LDL-C levels <70 mg/dL with statins. Monoclonal antibody targeting PCSK9 is a novel class of drug used in the treatment of Hypercholesterolemia. Alirocumab is one such human monoclonal antibody directed against PCSK9. Binding of PCSK9 to the LDL-R on the hepatocytes promotes LDL-R degradation. Inhibition of PCSK9 binding to LDL-R leads to increased number of LDL-Rs to clear LDL, thus decreasing LDL-C levels. The purpose of this systematic study is to assess the safety and efficacy of Alirocumab in adults with hypercholesterolemia and Familial hypercholesterolemia.
Materials And Methods:
We searched Medline, PubMed Central database, Google scholar, EBSCO, Wiley library, conference proceedings and Clinical trials.gov registry through March 2017. Phase 3 randomized, controlled trials (RCTs) using Alirocumab in adults with hypercholesterolemia and Familial Hypercholesterolemia were selected.
Results:
In twelve RCTs comprising of 6019 patients included in the meta-analysis, significant favorable changes in LDL-C and HDL-C were found.
Limitations:
Results were derived from study level data rather than patient level data.
Conclusions:
Alirocumab substantially reduced the LDL-C level by over 50 %, increased the HDL-C level, and resulted in favorable changes in other lipids.
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